Mycophenolic sodium - Generic Drug Details

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What are the generic sources for mycophenolic sodium and what is the scope of freedom to operate?

Mycophenolic sodium is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Alkem Labs Ltd, Amta, Apotex Inc, Aurobindo Pharma Ltd, Biocon Pharma, Concord Biotech Ltd, Rk Pharma, Teva Pharms Usa, Twi Pharms, Wanbang Biopharms, and Novartis, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

Eighteen suppliers are listed for this compound.

Summary for mycophenolic sodium

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	13
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	21
DailyMed Link:	mycophenolic sodium at DailyMed

Recent Clinical Trials for mycophenolic sodium

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
AstraZeneca	Phase 3
University Hospital, Tours	Phase 4
Lee's Pharmaceutical Limited	Phase 4

See all mycophenolic sodium clinical trials

Pharmacology for mycophenolic sodium

Drug Class	Antimetabolite Immunosuppressant

Paragraph IV (Patent) Challenges for MYCOPHENOLIC SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MYFORTIC	Delayed-release Tablets	mycophenolic sodium	180 mg	050791	1	2009-06-03
MYFORTIC	Delayed-release Tablets	mycophenolic sodium	360 mg	050791	1	2009-02-02

US Patents and Regulatory Information for mycophenolic sodium

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	MYCOPHENOLIC SODIUM	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	218603-002	Feb 27, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	MYCOPHENOLIC SODIUM	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	218603-001	Feb 27, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amta	MYCOPHENOLIC SODIUM	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	214376-002	Feb 10, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for mycophenolic sodium

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	MYFORTIC	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	050791-001	Feb 27, 2004	⤷ Sign Up	⤷ Sign Up
Novartis	MYFORTIC	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	050791-002	Feb 27, 2004	⤷ Sign Up	⤷ Sign Up
Novartis	MYFORTIC	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	050791-002	Feb 27, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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